PDS Biotechnology provides update from ongoing VERSATILE-002 Phase 2 trial

PDS Biotechnology provided a data update from its ongoing VERSATILE-002 Phase 2 clinical trial. VERSATILE-002 is evaluating Versamune HPV + KEYTRUDA in patients with HPV16-positive head and neck squamous cell cancer. The Kaplan-Meier analysis captures the survival data for immune checkpoint inhibitor naive patients from the ongoing VERSATILE-002 Phase 2 clinical trial. All patients whose data are reported in the Kaplan-Meier analysis are properly censored to confirm their follow-up and survival status. Based on a data cut as of May 17, 2024, the updated survival data for the cohort of ICI naive patients after an additional follow-up of approximately 6 months in the VERSATILE-02 Phase 2 clinical trial with a total of 53 enrolled patients was as follows: mOS is 30 months, consistent with data presented at the Company’s Key Opinion Leader event on May 9, 2024, which was based on a data cut as of November 30, 2023. 27 of the censored patients remained alive and were awaiting their next clinical assessment, 6 censored patients had withdrawn consent for further follow-up, and 2 patients had been lost to follow-up, and 18 patients had died. The lower limit of the 95% confidence interval is 19.7 months, and the upper limit is not yet estimable, as the majority of the patients continue to be followed for survival. Full data from the May 17, 2024 data cut are expected to be announced in Q3 2024.